System For Monitoring Compliant Usage Of Negative Pressure Wound Therapy

ABSTRACT

Systems, methods, and apparatuses for treating a tissue site are described. In some embodiments, the system may include a dressing, a negative-pressure source, and a communication device. The communication device may be coupled to the negative-pressure source and configured to transmit operational data of the negative pressure source to a remote location for monitoring usage of the system.

TECHNICAL FIELD

This disclosure relates generally to medical treatment systems fortreating tissue sites and monitoring the usage of such systems. Moreparticularly, but not by way of limitation, the disclosure relates to asystem for monitoring the compliant usage of negative-pressure woundtherapy systems.

BACKGROUND

Clinical studies and practice have shown that reducing pressure inproximity to a tissue site can augment and accelerate growth of newtissue at the tissue site. The applications of this phenomenon arenumerous, but it has proven particularly advantageous for treatingwounds. Regardless of the etiology of a wound, whether trauma, surgery,or another cause, proper care of the wound is important to the outcome.Treatment of wounds with reduced pressure may be commonly referred to as“negative-pressure therapy,” but is also known by other names, including“negative-pressure wound therapy,” “reduced-pressure wound therapy,”“vacuum therapy,” and “vacuum-assisted closure,” for example.Negative-pressure therapy may provide a number of benefits, includingmigration of epithelial and subcutaneous tissues, improved blood flow,and micro-deformation of tissue at a wound site. Together, thesebenefits can increase development of granulation tissue and reducehealing times.

While the clinical benefits of reduced-pressure therapy are widelyknown, development and operation of reduced-pressure systems,components, and processes continues to present significant challenges tomanufacturers, healthcare providers, and patients.

If a patient undergoing negative-pressure wound therapy does not usenegative-pressure systems in accordance with prescribed treatment plans,the outcomes of therapy may be less effective than desired. Currently,there is a lack of a real-time way of collecting such usage data formonitoring compliance with therapy protocols.

BRIEF SUMMARY

According to an illustrative embodiment, a system for monitoringtreatment of a tissue site may include a dressing, a negative-pressuresource, and a communication device. The dressing may be adapted forplacing on the tissue site. The negative-pressure source may be fluidlycoupled to the dressing. The communication device may be coupled to thenegative-pressure source and configured to transmit operational data ofthe negative-pressure source.

According to another illustrative embodiment, an apparatus for treatinga tissue site may include a negative-pressure source and a communicationdevice. The negative-pressure source may be adapted to be in fluidcommunication with the tissue site. The communication device may becoupled to the negative-pressure source and configured to transmitoperational data of the negative-pressure source.

According to yet another illustrative embodiment, a method for treatinga tissue site may include applying a dressing to the tissue site,coupling a negative-pressure source to the dressing, applying negativepressure to the dressing, and transmitting operational data related tothe application of the negative pressure.

Other objects, features, and advantages of the embodiments describedherein will become apparent with reference to the drawings and detaileddescription that follow.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an illustration of a therapy network in accordance with anexemplary embodiment;

FIG. 2 is a perspective view illustrating additional details that may beassociated with some example embodiments of a therapy unit in thetherapy network of FIG. 1;

FIG. 3 illustrates a screen shot of a graphical user interface (GUI) ofa therapy unit electronic display, according to an exemplary embodiment;

FIG. 4 illustrates a screen shot of a graphical user interface (GUI) ofa usage monitoring software for operation on an electronic device,according to an exemplary embodiment; and

FIG. 5 is a flow diagram of an exemplary process for monitoring theusage of a wound treatment system.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

In the following detailed description of non-limiting, illustrativeembodiments, reference is made to the accompanying drawings that form apart hereof. Other embodiments may be utilized, and logical, structural,mechanical, electrical, and chemical changes may be made withoutdeparting from the scope of the appended claims. To avoid detail notnecessary to enable those skilled in the art to practice the embodimentsdescribed herein, the description may omit certain information known tothose skilled in the art. The following detailed description isnon-limiting, and the scope of the illustrative embodiments are definedby the appended claims. As used herein, unless otherwise indicated, “or”does not require mutual exclusivity.

The example embodiments may also be described herein with reference tospatial relationships between various elements or to the spatialorientation of various elements depicted in the attached drawings. Ingeneral, such relationships or orientation assume a frame of referenceconsistent with or relative to a patient in a position to receivetreatment. However, as should be recognized by those skilled in the art,this frame of reference is merely a descriptive expedient rather than astrict prescription.

FIG. 1 is a schematic diagram of an example embodiment of a therapynetwork 100 that can provide monitored wound therapy in accordance withthis specification. The therapy network 100 may include a therapy system102, which may include a therapy unit 104 and a dressing 106. Thedressing 106 may include a cover 108 and a tissue interface 110. Thedressing 106 may be fluidly coupled to a negative-pressure source 114,as illustrated in FIG. 1. The therapy unit 104 may also include anexudate container, such as a container 112, fluidly coupled to thedressing 106 and to the negative-pressure source 114.

The therapy system 102 may also include a communication device 116. Forexample, the communication device 116 may be electrically coupled to thetherapy unit 104, or in some embodiments, may be part of the therapyunit 104. The communication device 116 may be connected to the therapyunit 104 by a wire or wirelessly. The communication device 116 of thetherapy system 102 may be configured to communicate with one or morenetworks 118 of the therapy network 100, and may include a transmitter.In one preferred embodiment, the communication device 116 may include acellular modem and may be configured to communicate with the network(s)118 through a cellular connection. In other embodiments, thecommunication device 116 may include a Bluetooth® radio, ZigBee® radio,or other wireless radio technology for communicating with the network(s)118 through a personal area network (PAN) or a wide personal areanetwork (WPAN). The communication device 116 may be configured totransmit data related to the operation of the therapy system 102, whichmay occur at a patient's home or at a treatment center, such as ahospital or physician's office.

In some embodiments, the communication device 116 may be integratedwithin the housing of the negative-pressure source 114 of the therapyunit 104. In other embodiments, the communication device may beseparately attached to the external surface of the negative-pressuresource 114, and may include a receiver configured to receive datarelated to the operation of the negative-pressure source 114. In oneembodiment, the communication device 116 may be attached to the externalsurface of the negative-pressure source 114 and may be connected to thenegative-pressure source 114 through a serial communication interface.

In some embodiments, the communication device 116 may include aprocessor that is configured with an algorithm for processing the datarelated to the operation of the therapy system 102, and morespecifically, the negative-pressure source 114. The processoralgorithm(s) may be programmed to compute usage statistics based on theusage time and conditions of the negative-pressure source 114. Forexample, the processor may compute the total operation time of thenegative-pressure source 114 since a given patient has begun treatment,as well as compute average daily operation time(s). The processor may beconfigured to calculate how an average daily operation time compareswith a prescribed therapy protocol and to compute a level of compliancewith the corresponding prescribed therapy protocol. Additionally, theprocessor may be configured to generate an alert signal based on thelevel of compliance with the prescribed therapy protocol, which may becommunicated through a network, such as network 118, by a transmitter ofthe communication device 116.

The therapy network 100 may also include a remote monitoring center 120that may be in communication with the therapy system 102 throughnetwork(s) 118. For example, the communication device 116 of the therapysystem 102 may be configured to transmit data through network(s) 118 tothe remote monitoring center 120. The remote monitoring center 120 mayinclude an automated monitoring center 122. The automated monitoringcenter 122 may include a communication center 124 as well as an alertcenter 126. The communication center 124 may be designed to monitor thecommunication links between therapy systems, such as therapy system 102,and the remote monitoring center 120. In some embodiments, thecommunication center 124 may include a receiving unit configured toreceive data related to the operation of the therapy system 102, andmore specifically the therapy unit 104 and the negative-pressure source114. The receiving unit may include a processing device loaded withsoftware algorithms for processing the data related to the operation ofthe therapy system 102 and for providing output calculations forcomparing how the data related to the operation of the therapy system102 compares to one or more threshold values. For example, in someembodiments, the threshold values may correspond to treatment protocolsthat prescribe a specific minimum amount of use of the therapy unit 104.

The alert center 126 of the automated monitoring center 122 may beconfigured to receive alert notifications communicated from the therapysystems, such as therapy system 102, as well as from the communicationcenter 124. In some cases, the communication center 124 and/or the alertcenter 126 may be operated by one or more automated computers. Theremote monitoring center 120 may also include a compliance team center128. The compliance team center 128 may function as a service center forcompliance staff, clinicians, or other personnel for monitoring usage oftreatment systems, such as treatment system 102, by patients, as well assend alert notifications that may be escalated from the alert center126.

The therapy network 100 may also include other entities that maycommunicate with therapy systems and remote monitoring centers throughnetwork(s) 118. For example, the therapy network 100 may include a thirdparty 130. For example, the third party 130 may be an insurer. In oneembodiment, the third party 130 may communicate through network(s) 118with the remote monitoring center 120 in order to acquire usage datarelated to the therapy system 102. In other embodiments, the third party130 may be able to receive usage data directly from a therapy systemthrough network(s) 118, without needing to communicate with a therapysystem.

In general, components of the therapy system 102 may be coupled directlyor indirectly, and in some cases, may be detachably coupled. Forexample, negative-pressure source 114 may be directly coupled tocontainer 112 and indirectly coupled to dressing 106 through container112. Components may be fluidly coupled to each other to provide a pathfor transferring fluids (i.e., liquid and/or gas) between thecomponents.

In some embodiments, components may be fluidly coupled with a tube, forexample. A “tube,” as used herein, broadly refers to a tube, pipe, hose,conduit, or other structure with one or more lumina adapted to conveyfluids between two ends. Typically, a tube is an elongated, cylindricalstructure with some flexibility, but the geometry and rigidity may vary.In some embodiments, components may additionally or alternatively becoupled by virtue of physical proximity, being integral to a singlestructure, or being formed from the same piece of material. Coupling mayalso include mechanical, thermal, electrical, or chemical coupling (suchas a chemical bond) in some contexts.

In operation, the tissue interface 110 may be placed within, over, on,or otherwise proximate to a tissue site. The cover 108 may be placedover the tissue interface 110 and sealed to tissue near the tissue site.For example, the cover 108 may be sealed to undamaged epidermisperipheral to a tissue site. Thus, the dressing 106 can provide a sealedtherapeutic environment proximate to a tissue site, substantiallyisolated from the external environment, and the negative-pressure source114 can reduce the pressure in the sealed therapeutic environment.Negative pressure applied to a tissue site through the tissue interface110 in the sealed therapeutic environment can induce macro-strain andmicro-strain in the tissue site, as well as remove exudates and otherfluids from the tissue site, which can be collected in the container 112and disposed of properly.

The fluid mechanics of using a negative-pressure source to reducepressure in another component or location, such as within a sealedtherapeutic environment, can be mathematically complex. However, thebasic principles of fluid mechanics applicable to negative-pressuretherapy are generally well-known to those skilled in the art.

In general, exudates and other fluids flow toward lower pressure along afluid path. Thus, the term “downstream” typically implies something in afluid path relatively closer to a source of negative pressure or furtheraway from a source of positive pressure; conversely, the term “upstream”implies something relatively further away from a source of negativepressure or closer to a source of positive pressure. Similarly, it maybe convenient to describe certain features in terms of fluid “inlet” or“outlet” in such a frame of reference, and the process of reducingpressure may be described illustratively herein as “delivering,”“distributing,” or “generating” reduced pressure, for example. Thisorientation is generally presumed for purposes of describing variousfeatures and components herein.

The term “tissue site” in this context broadly refers to a wound ordefect located on or within tissue, including but not limited to, bonetissue, adipose tissue, muscle tissue, neural tissue, dermal tissue,vascular tissue, connective tissue, cartilage, tendons, or ligaments. Awound may include chronic, acute, traumatic, subacute, and dehiscedwounds, partial-thickness burns, ulcers (such as diabetic, pressure, orvenous insufficiency ulcers), flaps, and grafts, for example. The term“tissue site” may also refer to areas of any tissue that are notnecessarily wounded or defective, but are instead areas in which it maybe desirable to add or promote the growth of additional tissue. Forexample, negative pressure may be used in certain tissue areas to growadditional tissue that may be harvested and transplanted to anothertissue location.

“Negative pressure” generally refers to a pressure less than a localambient pressure, such as the ambient pressure in a local environmentexternal to a sealed therapeutic environment provided by dressing 106.In many cases, the local ambient pressure may also be the atmosphericpressure at which a patient is located. Alternatively, the pressure maybe less than a hydrostatic pressure associated with tissue at the tissuesite. Unless otherwise indicated, values of pressure stated herein aregauge pressures. Similarly, references to increases in negative pressuretypically refer to a decrease in absolute pressure, while decreases innegative pressure typically refer to an increase in absolute pressure.

A negative-pressure source, such as the negative-pressure source 114,may be a reservoir of air at a negative pressure, or may be a manual orelectrically-powered device that can reduced the pressure in a sealedvolume, such as a vacuum pump, a suction pump, a wall suction portavailable at many healthcare facilities, or a micro-pump, for example. Anegative-pressure source may be housed within or used in conjunctionwith other components, such as sensors, processing units, alarmindicators, memory, databases, software, display devices, or userinterfaces that further facilitate reduced-pressure therapy. While theamount and nature of negative pressure applied to a tissue site may varyaccording to therapeutic requirements, the pressure typically rangesbetween −5 mm Hg (−667 Pa) and −500 mm Hg (−66.7 kPa). Commontherapeutic ranges are between −75 mm Hg (−9.9 kPa) and −300 mm Hg(−39.9 kPa).

The tissue interface 110 can be generally adapted to contact a tissuesite. The tissue interface 110 may be partially or fully in contact witha tissue site. If a tissue site is a wound, for example, the tissueinterface 110 may partially or completely fill the wound, or may beplaced over the wound. The tissue interface 110 may take many forms, andmay have many sizes, shapes, or thicknesses depending on a variety offactors, such as the type of treatment being implemented or the natureand size of a tissue site. For example, the size and shape of the tissueinterface 110 may be adapted to the contours of deep and irregularshaped tissue sites.

In some embodiments, the tissue interface 110 may be a manifold. A“manifold” in this context generally includes any substance or structureproviding a plurality of pathways adapted to collect or distribute fluidacross a tissue site. For example, a manifold may be adapted to receivenegative pressure from a source and distribute negative pressure throughmultiple apertures across a tissue site, which may have the effect ofcollecting fluid from across a tissue site and drawing the fluid towardthe source. In some embodiments, though, a manifold may also facilitatedelivering fluids to a tissue site, if the fluid path is reversed or asecondary fluid path is provided, for example.

In some illustrative embodiments, the pathways may be interconnected toimprove distribution or collection of fluids provided to or removed froma tissue site. For example, cellular foam, open-cell foam, porous tissuecollections, and other porous material such as gauze or felted matgenerally include structural elements arranged to form flow channels.Liquids, gels, and other foams may also include or be cured to includeflow channels.

In some illustrative embodiments, a manifold may be a porous foammaterial having interconnected cells or pores adapted to distributenegative pressure across a tissue site. The foam material may be eitherhydrophobic or hydrophilic. In one non-limiting example, the tissueinterface 110 may be an open-cell, reticulated polyurethane foam such asGranuFoam® dressing available from Kinetic Concepts, Inc. of SanAntonio, Tex.

In an example in which the tissue interface 110 may be made from ahydrophilic material, the tissue interface 110 may also wick fluid awayfrom a tissue site, while continuing to distribute negative pressure tothe tissue site. The wicking properties of the tissue interface 110 maydraw fluid away from a tissue site by capillary flow or other wickingmechanisms. An example of a hydrophilic foam is a polyvinyl alcohol,open-cell foam such as V.A.C. WhiteFoam® dressing available from KineticConcepts, Inc. of San Antonio, Tex. Other hydrophilic foams may includethose made from polyether. Other foams that may exhibit hydrophiliccharacteristics include hydrophobic foams that have been treated orcoated to provide hydrophilicity.

The tissue interface 110 may further promote granulation at a tissuesite when pressure within the sealed therapeutic environment is reduced.For example, any or all of the surfaces of the tissue interface 110 mayhave an uneven, coarse, or jagged profile that can induce microstrainsand stresses at a tissue site if negative pressure is applied throughthe tissue interface 110.

In some embodiments, the tissue interface 110 may be constructed frombioresorbable materials. Suitable bioresorbable materials may include,without limitation, a polymeric blend of polylactic acid (PLA) andpolyglycolic acid (PGA). The polymeric blend may also include withoutlimitation polycarbonates, polyfumarates, and capralactones. The tissueinterface 110 may further serve as a scaffold for new cell-growth, or ascaffold material may be used in conjunction with the tissue interface110 to promote cell-growth. A scaffold is generally a substance orstructure used to enhance or promote the growth of cells or formation oftissue, such as a three-dimensional porous structure that provides atemplate for cell growth. Illustrative examples of scaffold materialsinclude calcium phosphate, collagen, PLA/PGA, coral hydroxy apatites,carbonates, or processed allograft materials.

In some embodiments, the cover 108 may provide a bacterial barrier andprotection from physical trauma. The cover 108 may also be constructedfrom a material that can reduce evaporative losses and provide a fluidseal between two components or two environments, such as between atherapeutic environment and a local external environment. The cover 108may be, for example, an impermeable or semi-permeable, elastomericmaterial that can provide a seal adequate to maintain a negativepressure at a tissue site for a given negative-pressure source. In someexample embodiments, the cover 108 may be a polymer drape, such as apolyurethane film, that is permeable to water vapor but impermeable toliquid. Such drapes typically have a thickness in the range of 25-50microns. For permeable materials, the permeability generally should below enough that a desired negative pressure may be maintained.

An attachment device may be used to attach the cover 108 to anattachment surface, such as undamaged epidermis, a gasket, or anothercover. The attachment device may take many forms. For example, anattachment device may be a medically-acceptable, pressure-sensitiveadhesive that extends about a periphery, a portion, or the entire cover108. In some embodiments, for example, some or all of the cover 108 maybe coated with an acrylic adhesive having a coating weight between 25-65grams per square meter (g.s.m.). Thicker adhesives, or combinations ofadhesives, may be applied in some embodiments to improve the seal andreduce leaks. Other example embodiments of an attachment device mayinclude a double-sided tape, paste, hydrocolloid, hydrogel, siliconegel, or organogel.

The container 112 is representative of a container, canister, pouch, orother storage component, which can be used to manage exudates and otherfluids withdrawn from a tissue site. In many environments, a rigidcontainer may be preferred or required for collecting, storing, anddisposing of fluids. In other environments, fluids may be properlydisposed of without rigid container storage, and a re-usable containercould reduce waste and costs associated with negative-pressure therapy.

Referring to FIG. 2, depicted is an illustrative example of a therapyunit 204 according to one embodiment, and may be another embodiment ofthe therapy unit 104. Therapy unit 204 is suitable for use as acomponent of the therapy system 102. The therapy unit 204 may include ahousing 205, which may enclose a negative-pressure source 214 and acommunication device 216. The therapy unit may also include anelectronic display 217 for interfacing with a user. A container 212 maybe configured to attach to the housing 205 of the therapy unit 204.

Referring to FIG. 3, an example embodiment of the electronic display 217of the therapy unit 204 is shown. The electronic display 217 may beconfigured to display a graphical user interface (GUI) 300. The GUI 300may include a number of selectable graphical elements, including a“settings” soft-button 306, “treatment protocol” soft-button 308, “usagedata” soft-button 310, and “communications” soft-button 312, along withsoft-buttons assigned to any other features related to the treatment ofa tissue site. A user may select any of these functions (i.e., settings,wound type, treatment protocol, usage data, communications) to cause theelectronic display 217 to present the user with another graphical userinterface for performing the selected function. In addition, an “exit”soft-button 314 may be available to the user to exit the current GUI300. It should be understood that the GUI 300 is exemplary and thatother and/or alternative functions and selection elements may beprovided to the user.

An information region 316 on the GUI 300 may include selectablegraphical elements and display other information in which the user maybe interested. For example, a “help” soft-button 318 may be displayed toenable the user to receive help about the therapy unit 204 or particularfunctions currently being displayed on the GUI 300. A “transmit”soft-button 320 may enable a user to selectively activate or deactivatethe communication device 216 of the therapy system 102 to begin or ceasetransmitting usage data to the network(s) 118. An “on-off” soft-button322 may enable a user to selectively turn the therapy unit 204 on andoff. Information status region 324 may notify the user of current statusof the therapy unit 204. For example, the information status region 324may indicate that the therapy unit 204 is (i) currently on, (ii)operating according to a specifically-selected treatment protocol, and(iii) transmitting operational data to remote receiver. The informationstatus region 324 may also indicate whether the communication device 216is (i) currently activated, (ii) currently deactivated, (iii) currentlytransmitting data, and (iv) currently receiving data. The informationstatus region 324 may also provide a visual indication of the compliancelevel of a patient's usage of the therapy system 102 with a prescribedtreatment protocol.

In some embodiments, the therapy system 102 may be configured to displayusage compliance information on the information status region 324 forthe user, or to notify a caregiver or other service provider, that theuser, such as a patient, is complying with a prescribed treatmentprotocol. For example, usage compliance information may includeinformation or data regarding whether or not negative pressure therapyis being applied to the tissue site over time. Usage complianceinformation also may include information or data regarding a therapyevent log tracking, for example, whether the therapy system 102 isturned on or off over time. Additional compliance analysis may includeinformation or data regarding whether or not the therapy system 102 isbeing utilized in compliance with a prescribed treatment protocol suchas, for example, a protocol defining different pressures and/or flowrates over time. Compliance analysis may also include information ordata regarding wound healing progress over time. Additional complianceoutput information may include output data and information such as, forexample, information providing an audible or visual alert whennon-compliance reaches an unacceptable level or threshold. Such outputcompliance information also may provide feedback to the user, such as apatient, before providing such information to others, such asclinicians, so that the user has an opportunity and is motivated tocorrect a non-compliant situation before reaching an unacceptable levelor threshold. Additional compliance input information may include inputdata and information such as, for example, information regarding thesettings or caregiver input entered into the therapy system 102. Suchinput compliance information may include, for example, therapeuticpressure settings, maximum and minimum target pressures, flow ratesettings, the intensity and/or duration of any complementary treatmentsuch as instillation of fluids, and data indicating whethernegative-pressure treatment is being applied in a continuous orintermittent mode of operation.

The information status region 324 may also be configured to displaymessages communicated from a remote party to the user. For example, aclinician at the remote monitoring center 120 may send messages throughnetwork(s) 118 to the therapy system 102 for display to a patient. Suchmessages may include instructions to keep the therapy system 102 turnedon and utilized. Additionally, such messages may include instructionsfor troubleshooting one or more issues presented with the therapy system102. Troubleshooting instructions may include directions to empty orchange an exudate container or recharge or replace a battery of thetreatment system 102.

FIG. 4 shows a screen shot of an illustrative GUI 400 of an exemplaryembodiment of usage-monitoring software, or another embodiment of theGUI 300 or a portion of the GUI 300, for use on an electronic device,such as a computer having an electronic display, which may be theelectronic display 217 that includes the GUI 300. This exemplaryembodiment of GUI 400 provides a patient summary view 402, whichincludes usage compliance information embodied in a usage reportsdisplay 404, a compliance analysis display 406, and compliance outputinformation embodied in an alert management display 408. The usagereports display 404 may correspond to usage data regarding a patient'stherapy system, such as therapy system 102. The patient summary view 402may display information based on data from device log data of a therapysystem. The device log data is interpreted and manipulated by theusage-monitoring software in preparation for display. Theusage-monitoring software may parse the date- and time-stamped data tocalculate potential non-compliant use statistics.

The usage reports display 404 may include a daily usage summary 410,which may display to a user the total amount of time per day that atherapy system is running. The usage reports display 404 may alsoinclude a healing measurements display 412. The healing measurementsdisplay 412 may provide data for tracking the healing progression of oneor more wounds of a patient. For example, the healing measurementsdisplay 412 may display data corresponding to the percentage of healingthat a specific wound has undergone. Additionally, or alternatively, thehealing measurements display 412 may display data relating to physicalmeasurements of one or more wounds, such as length, width, depth,circumference dimensions, as well as others.

The compliance analysis display 406 may display data and analysisrelated to a patient's usage of a therapy system, such as therapy system102, and how this usage complies with one or more treatment protocol(s).For example, compliance chart 414 may display a comparison of the amountof time a patient uses a therapy system each day versus the amount oftime prescribed according to a treatment protocol. The complianceanalysis display 406 may also include a healing analysis chart 416,which may compare the rate of healing of one or more wounds of a patientto average healing times for similar wound(s). Alternatively, thecompliance analysis display 406 may display analysis related to theparticular timeframe(s) during days or nights when a therapy system isused. The compliance analysis display 406 may also, or alternatively,display statistics related to any other aspects of a patient's usage ofa therapy system or the healing of one or more wound(s).

The alert management display 408 may display information related todifferent types of alarms or warnings associated with the use of atreatment system, such as treatment system 102. For example, the alertmanagement display 408 may include an alarms window 418 and acommunications window 420. The alarms window 418 may include one or moreindicators related to different features or functionalities of a therapysystem. For example, the alarms window 418 may include a leak detectionindicator 422, which may signal a user that a fluid leak has beendetected on the patient's therapy system. The alarms window 418 may alsoinclude a block detection indicator 424, which may alert a user that afluid blockage has been detected by the therapy system. A container fullindicator 426, which indicates that a container for collecting woundexudate is or is nearing full, may also be included. Additionally, a lowbattery indicator 428 may be included, for signaling that one or morebatteries of a therapy system are nearing depletion. Furthermore, thealert management display 408 may allow for remotely troubleshootingissues with the therapy system 102.

The communications window 420 of the alert management display 408 maydisplay alerts to a user regarding the connection status with one ormore therapy systems, as well as provide a user interface for viewingand changing settings related to communicating with the therapysystem(s). For example, the communications window 420 may include anuplink fault indicator 430, which may signal to a user that acommunication link with a therapy system being monitored has beeninterrupted. A configuration button 432 may also be included forallowing a user to access a menu for configuring the communicationsand/or network settings for establishing and maintaining remotemonitoring functionality of a therapy system.

While the illustrative GUI 400 of FIG. 4 is focused on individualpatient data, other illustrative GUIs may include reports focused onsummary data for a broad base of patients. For example, an overview of agiven patient population could be provided, which may provide forefficient identification of patient outliers who may requireintercession. Such overviews may include viewing patient data on a macrolevel, for example, by grouping patient data by patient demographics,payer groups, wound types, or comorbidities. Providing summary views ofone or more patient populations may allow for better insight intopatient care on a broader scale.

In the typical homecare setting, patients undergoing wound treatment arevisited once every 2-3 days for wound dressing changes, at which timethe clinician may assess patient compliance in following a prescribedtherapy protocol. A clinician may use the GUI 404 and its featuresdescribed above of the therapy system 102 and/or additionally visuallyinspect the tissue site in order to make such assessment. However,visiting a patient once every 2-3 days is not optimal timing fordetermining whether patients have been using a negative-pressure therapysystem as prescribed (e.g., for the recommended number of therapy hoursper day). In many cases, providers and insurers expect that patients areusing the negative-pressure therapy system 24 hours per day, howeveractual use by some patients may be much lower. Lacking any way tocollect this usage data, the extent of the compliance issue is largelyunknown. Non-compliance below certain thresholds is now understood tohave an effect on patient healing.

As disclosed herein, the therapy network 100 improves the administrationof negative-pressure wound therapy. For example, by providing a systemfor remotely monitoring usage compliance of a negative-pressure therapysystem, noncompliant usage could be more quickly detected so thatcaregivers and patients can be more quickly advised to utilize thetherapy systems as prescribed. As a result, increased compliance withtreatment protocols could be achieved and faster healing of tissue sitescould be accomplished. For example, a clinical care team or ahome-health nurse may be able to contact a monitored patient to provideinstructions for becoming compliant with a given prescribed treatment.

In operation, the therapy network 100 and its various components andfeatures may be used in accordance with the exemplary embodiment of amonitoring method 500 illustrated in FIG. 5. For example, operation ofthe therapy network 100 may begin with initiating operation of a therapysystem, such as the therapy system 102. A dressing, such as dressing 106of therapy system 102, may be applied to a tissue site, as shown in step502. Negative pressure may then be applied to the dressing and tissuesite, by fluidly connecting a negative-pressure source, such asnegative-pressure source 114, to the dressing and then activating thenegative-pressure source, as illustrated in step 504. Step 506 providesthe process of activating the communications capability of a therapysystem, and establishing communication with one or more remotemonitoring centers in order to begin transmitting data, such as usagedata.

Once a therapy system has begun transmitting data, usage data may bereceived and analyzed at a remote location, such as a remote monitoringcenter, as indicated in step 508. A user, for example a clinician or acompliance team member, located at a remote location may review usagedata that is transmitted from a therapy system related to a specificpatient by using a GUI. In some instances, the GUI may be viewed on acomputing device, such as a desktop terminal. In other instances, theGUI may be viewed on a personal wireless device, such as a smartphone,using a proprietary software application.

In some preferred embodiments, such usage data and, specifically, usagecompliance information, may include when a therapy unit, such as therapyunit 204, is on or off. In other embodiments, such usage complianceinformation may further include whether a communication device, such ascommunication device 216, is activated or deactivated during a giventime period, and or furthermore, whether the communication device 216 istransmitting data to a remote receiver when activated. Additionally, theusage compliance information received may be analyzed to determinewhether it complies with the desired usage data to be transmitted.

Upon reviewing such usage compliance information, the user may make adetermination of whether a patient's usage of a therapy system is incompliance with one or more prescribed protocol(s), as illustrated instep 510. In some embodiments, an automated monitoring capability may beemployed, and this determination of compliance may be madeautomatically. If the compliance assessment determines that thepatient's therapy system is being used according to a given prescribedprotocol, step 508 may be repeated according to a routine monitoringschedule. In the alternative, should the compliance assessment performedin step 510 indicate that a patient's therapy system is not being usedaccording to a prescribed treatment protocol, an alert may be signaledat a remote monitoring center, as shown in step 512.

For example, if a patient who has been prescribed 24 hours/day ofnegative-pressure therapy for a wound is only using thenegative-pressure treatment system for approximately 14 hours/day, theremote monitoring center may detect this discrepancy between prescribedand actual treatments. In some preferred embodiments, threshold alertsmay be set for when usage compliance of negative-pressure therapy fallsbelow an amount of time between 16 hours/day to 20 hours/day dependingon other therapeutic factors and wound conditions. For instance, theinput compliance threshold may be set at 18 hours/day if the complianceteam decides that the present therapy is generating high amounts ofwound exudate volumes may be impeding the healing process. In anotherexample, the input compliance threshold may be set at 16 hours/day toaccommodate the administration of fluid instillation therapy. In any ofthe embodiments, the alert threshold limits may be adjusted to accountfor other factors that may affect the administration ofnegative-pressure therapy.

While often it is preferred that patients are administerednegative-pressure therapy to a wound for as close to 24 hours/day aspossible, usage compliance thresholds, such as those discussed above,may be set based on empirical data indicating that usage time iscritical for wound healing progression. Wound healing progression may bemeasured by the percent reduction of wound volume per day, i.e., woundvolume reduction. Studies generating empirical data have indicated thatwound volume reduction may be enhanced by the percentage of a 24-hourday that the negative-pressure therapy is administered, i.e., usagepercentage. Moreover, there may be significant differences in the woundvolume reduction between certain usage percentage values, indicatingwhich usage percentage values or ranges are thresholds to be targetedfor usage compliance.

As can be seen from the data in Table 1, one critical threshold mayexist between the 60-69% usage percentage range (approximately 14.5 to16.5 hours per day) and the 70-79% usage percentage range (approximately17 to 19 hours per day). Thus, based on this data, in order to achieve adesired wound volume reduction per day of greater than about 1.5%, auser should adhere to a negative-pressure therapy compliance thresholdof at least about 70%, or about 17 hours per day, to avoid an alarmwarning of non-compliance.

TABLE 1 Usage Percentage of 24- Wound Volume Hour Day During Course ofReduction/ Number of Patients Therapy (%) Day (%) (n = 1843)  <50% 1.14%959 50-59% 1.26% 377 60-69% 1.34% 195 70-79% 1.61% 127 80-89% 1.81% 7490-100%  2.14% 111

In addition to an alert being signaled at the remote monitoring center,an automated user message may be initiated by the remote monitoringcenter and sent to the therapy system, as illustrated in step 514. Forexample, a user message received by the therapy system may automaticallybe displayed on the GUI of the therapy system. In some embodiments, achime or other form of alert may accompany the display of message, inorder to attract the attention of the user. In other embodiments, a usermessage may be sent by the remote monitoring center through the networkto the user using other means. Some examples of other messaging forms ofcommunication may include sending a text message to a phone number onrecord for a particular user. Similarly, an email may be sent to anaddress on file for the user. In another embodiment, an automatedtelephone message may be delivered to a phone number on record for auser.

Following such a message being delivered to a user, usage monitoring maycontinue, as shown in step 516, particularly for detecting indicationsof improved compliance with the treatment protocol. Step 518 illustratesthat usage data may again be analyzed, similarly to the type of dataanalysis performed in step 510, to determine if a patient has improvedhis or her compliance of using a treatment system with a given treatmentprotocol, for example, whether a designated usage threshold, such as 20hours/day, is being met. In some cases, the determination as to whethera designated usage threshold is being met or exceeded may be evaluatedon a daily basis, or may be evaluated as an average over a multiple dayperiod. For example, the wound volume percentage reductions per dayshown in Table 1 may be determined by averaging the wound volumepercentage reduction over a period of several days. Additionally, thedesignated usage threshold may vary over time, such as being increasedor reduced from one week to another. For example, in cases where aparticular tissue site has shown significant healing progress, thethreshold may be reduced. However, on the other hand, in cases wherehealing progress is less than desired, possibly due to lack ofcompliance with a given treatment protocol, the designated usagethreshold may be increased for a period of time.

In one embodiment, an alert is generated if usage per day falls below 14hours. In another embodiment an alert is generated if usage per dayfalls below 16 hours or 18 hours or usage per day in the range of 14hours to 22 hours. Alternatively, or additionally, an alert may begenerated if the average usage over a multiday time period falls below14 hours, 16 hours, or 18 hours or average usage in the range of 14hours to 22 hours. For example, if usage drops below an average of 15hours over a three day time period or if usage drops below an average of17 hours over a three day time period.

The threshold for generating an alert may be adjusted over time. In oneembodiment, the threshold is set within a first higher range, such asfor example, 18 hours to 22 hours. Later the threshold may be set at alower range, such as for example, 14 hours to 16 hours. The thresholdalternatively may be adjusted based on a signal received for a user orcaregiver. For example, if the system receives a signal indicating ahigher risk patient, such as for example, a patient first beginningtherapy, a patient with an infected wound, or a patient with one or moreco-morbidities, the system will utilize a higher usage threshold. Uponthe system receiving a different signal from a user or patient, thesystem may set a lower usage threshold. A low-risk patient signal mightbe received for patients who have been compliant, patients with woundsthat are healing or healed sufficiently, or patients visited often bycaregivers.

For example, if a signal is received indicating compliance has improved,or the system determines compliance has improved, a routine monitoringschedule of treatment system usage may be resumed, as illustrated instep 508. In the event that the analyzed usage data indicates that therehas not been improved compliance with a given treatment protocol, aclinician or other compliance team member may be alerted, as shown instep 520. For example, in some embodiments, an alert may be triggered inthe alert center 126 of the automated monitoring center 122 and thencommunicated to the compliance team center 128 of the remote monitoringcenter 120. Upon review of the alert, a clinician or other complianceteam member may contact the patient, as shown in step 522, in an effortto improve compliance with the treatment protocol. Furthermore, patientsmonitored by or assigned to a given clinician may be prioritized basedon the severity of non-compliance.

As used herein, usage refers to time a medical device is turned on.Alternatively, usage may mean the time when therapy is being delivered.In another aspect, usage may be measured by the time a device isdelivering target therapy. For example, the signal received by thesystem may indicate the usage by a sensor sending a message that thedevice has been turned on or off, or a pump has been turned on or off.The medical device may store data about usage and then send a signal tothe system indicating usage on a hourly, daily, or multi day timeperiod.

Following such contact by a clinician or other compliance team member,compliant usage monitoring may continue as shown in step 524. Similarly,step 526 illustrates that usage data may continue to be analyzed,similarly to the type of data analysis performed in steps 510 and 518.Once again, if compliance is determined to be improved, routinemonitoring of treatment system usage may be resumed, in accordance withstep 508. Should compliance with a prescribed treatment protocol not beimproved, an alert regarding the non-compliance may be escalated withinthe compliance monitoring team, as shown in step 528, so that furtheraction may be taken to improve patient care.

The systems and methods described herein may provide significantadvantages, some of which have already been mentioned. For example,current methods of monitoring patient compliance require in-personreview of device event logs at a patient's bedside. Manual calculationsand analysis are required to determine the amount of time ofnon-compliance. In some instances, in order to determine 2-3 days ofdevice usage, a clinician could spend up to ten minutes performing thecalculations and analysis, which is not practical in the modern-dayhealth care environment. As a solution, the remote therapy network asdescribed above provides ready access wherever the Internet is available(desktop computer, smart phone, smart tablet, etc.) for a clinician toview patient compliance information. The therapy network 100 may provideanalysis of the data output in order to provide caregivers informationin a meaningful format. No calculations are necessary and the cliniciancan be alerted to provide feedback to the patient to improve compliancewhen needed. Based on the data studied, it is expected that thisinvention will improve wound healing over standard stand-alonenegative-pressure wound therapy.

The therapy network 100 may provide improved patient monitoring. Forexample, device log data may be viewed remotely by numerousstakeholders, which may increase the frequency of interactions with agiven patient. As a result, providers may be enabled to more promptlyadjust treatment protocols, which may result in reduced healing timesfor tissue sites, as well as overall reduced costs of treatment.

Although certain illustrative, non-limiting exemplary embodiments havebeen presented, various changes, substitutions, permutations, andalterations can be made without departing from the scope of the appendedclaims. Any feature described in connection to any one exemplaryembodiment may also be applicable to any other exemplary embodiment.

Further, the steps of the methods described herein may be carried out inany suitable order, or simultaneously where appropriate.

We claim:
 1. A system for monitoring negative-pressure treatment of atissue site, comprising: a negative-pressure source; a dressing fluidlycoupled to the negative-pressure source and adapted to be disposed onthe tissue site for distributing negative pressure; and a communicationdevice coupled to the negative-pressure source and configured totransmit operational data of the negative-pressure source.
 2. The systemof claim 1, wherein the communication device is encased in thenegative-pressure source.
 3. The system of claim 1, further comprising acontainer fluidly coupled to the negative-pressure source and thedressing and configured to collect fluids.
 4. The system of claim 1,further comprising a connection interface configured to fluidly connectthe negative-pressure source to the dressing.
 5. The system of claim 1,wherein the dressing comprises: a tissue interface adapted to be placedproximate to the tissue site; and a cover adapted to be placed over thetissue interface.
 6. The system of claim 1, wherein the communicationdevice further comprises: a receiver configured to receive operationaldata from the negative-pressure source; a processor configured toprocess the operational data to compute one or more usage statistics;and a transmitter configured to transmit the one or more usagestatistics to a remote receiver for providing an alert signal indicatinga level of compliance with a prescribed protocol.
 7. The system of claim6, wherein the one or more usage statistics indicates whether a usagetime of the negative-pressure source meets a threshold value.
 8. Thesystem of claim 7, wherein the threshold value is in a range of about 14hours/day to 22 hours/day.
 9. The system of claim 8, wherein thethreshold value is about 14 hours/day.
 10. The system of claim 8,wherein the threshold value is about 16 hours/day.
 11. The system ofclaim 8, wherein the threshold value is about 18 hours/day.
 12. Thesystem of claim 6, wherein the communication device is furtherconfigured to receive data from the remote receiver.
 13. The system ofclaim 6, wherein the operational data is the on and off state of thenegative pressure source.
 14. A negative-pressure device for treating atissue site, comprising: a negative-pressure source adapted to be influid communication with the tissue site; and a communication devicecoupled to the negative-pressure source and configured to transmitoperational data of the negative-pressure source, wherein theoperational data indicates whether a usage time of the negative-pressuredevice meets a threshold value.
 15. The negative-pressure device ofclaim 14, further comprising an electronic display configured to displaythe operational data.
 16. The negative-pressure device of claim 15,wherein the electronic display is a touch-screen display configured toallow a user to control the transmittal of the operational data.
 17. Thenegative-pressure device of claim 14, wherein the electronic display isfurther configured to display an alert indicator.
 18. Thenegative-pressure device of claim 17, wherein the alert indicator islinked to usage time of the negative-pressure device.
 19. Thenegative-pressure device of claim 17, wherein the alert indicator islinked to at least one of a battery level, a fluid blockage, or acontainer fill level.
 20. The negative-pressure device of claim 14,wherein the communication device comprises a cellular modem.
 21. Thenegative-pressure device of claim 14, wherein the communication devicecomprises a radio configured to communicate on a personal area network.22. The negative-pressure device of claim 14, wherein the thresholdvalue is set based on a signal received from a patient or caregiver. 23.The negative-pressure device of claim 14, wherein the threshold value isin a range of about 14 hours/day to 22 hours/day.
 24. Thenegative-pressure device of claim 23, wherein the threshold value isabout 15 hours/day.
 25. The negative-pressure device of claim 23,wherein the threshold value is about 17 hours/day.
 26. Thenegative-pressure device of claim 23, wherein the threshold value isabout 19 hours/day.
 27. A method for treating a tissue site, comprising:applying a dressing to the tissue site; coupling a negative-pressuresource to the dressing; applying negative pressure to the dressing; andtransmitting operational data related to the application of the negativepressure.
 28. The method of claim 27, further comprising receiving thetransmitted operational data at a remote receiver.
 29. The method ofclaim 28, wherein the received operational data comprises usage data ofthe negative-pressure source.
 30. The method of claim 27, wherein theoperational data is transmitted as the negative pressure is applied tothe dressing.
 31. The method of claim 27, wherein the operational datais collected and transmitted at the conclusion of negative-pressurebeing applied to the dressing.
 32. The method of claim 28, furthercomprising receiving data from a remote receiver.
 33. The method ofclaim 27, wherein the operational data indicates whether a usage time ofthe negative-pressure source meets a threshold value.
 34. The method ofclaim 33, wherein the threshold value is in a range of about 14hours/day to 22 hours/day.
 35. The method of claim 34, wherein thethreshold value is about 17 hours/day.
 36. The method of claim 33,wherein the threshold value represents an average over a multiple dayperiod.
 37. The method of claim 27, further comprising remotelytroubleshooting one or more identified issues with a treatment systembased on the transmitted operational data.
 38. The method of claim 33,further comprising generating an alert if the usage time of thenegative-pressure source is less than the threshold value.
 39. Themethod of claim 27, wherein the operational data includes an indicationthat one or more operational parameters are out of a desired range. 40.The method of claim 39, wherein the operational parameters comprisenegative pressure measurements.
 41. The method of claim 39, wherein theoperational parameters comprise leak detection measurements.
 42. Themethod of claim 39, further comprising signaling an alarm based on theindication.
 43. A method for treating a tissue site, comprising:activating a negative-pressure source configured to provide negativepressure to the tissue site; transmitting data related to a usage timeof the negative-pressure source; determining that the usage time is lessthan a threshold value; generating an alert to signal that the usagetime is less than the threshold value.
 44. The method of claim 43,wherein the threshold value is in a range of about 14 hours/day to 22hours/day.
 45. The method of claim 44, wherein the threshold value isabout 17 hours/day.
 46. The method of claim 43, wherein the usage timeis an average number of hours per day from two or more days.
 47. Amethod for treating a tissue site, comprising: activating anegative-pressure source; transmitting data related to a usage time ofthe negative-pressure source to a remote user; and generating athreshold value based on the data related to the usage time.
 48. Themethod of claim 47, wherein the threshold value is a number of hours perday that is greater than the usage time.
 49. The method of claim 47,wherein the threshold value is a number of hours per day that is lessthan the usage time.
 50. A system for monitoring negative-pressuretherapy, comprising: a negative-pressure therapy unit; a dressingfluidly coupled to the negative-pressure therapy unit; a communicationdevice coupled to the negative-pressure therapy unit and configured totransmit operational data of the negative-pressure therapy unit; and areceiving unit configured to receive operational data transmitted fromthe communication device, wherein the receiving unit comprises aprocessor configured to process the operational data to provide anoutput determination of whether a usage time of the negative-pressuretherapy unit meets a threshold value.
 51. The system of claim 50,wherein the threshold value is in a range of about 14 hours/day to 22hours/day.
 52. The system of claim 51, wherein the threshold value isabout 16 hours/day.
 53. The system of claim 51, wherein the thresholdvalue is about 18 hours/day.
 54. The systems, apparatuses, and methodssubstantially as described herein.